Status:
COMPLETED
Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the feasibility of using more advanced IMRT (intensity modulated radiation therapy) techniques. This new technique is termed Temporally Feathered Radiation Therapy (TFRT). TFR...
Detailed Description
The primary objective of this study is to determine the feasibility of TFRT planning and delivery for head and neck squamous cell carcinoma. Secondary objectives include estimating grade 3-5 acute tox...
Eligibility Criteria
Inclusion
- Subjects must have histologically or cytologically confirmed squamous cell carcinoma arising from a primary head and neck site (oral cavity, oropharynx, larynx/hypopharynx, nasopharynx).TX-4, NX-3, MX-0 stages are permitted.
- Subjects must be eligible for definitive radiation therapy (70Gy in 35 fractions) with or without chemotherapy.
- Karnofsky Performance status ≥80.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Subjects receiving any other investigational agents.
- Postoperative radiotherapy is not permitted.
- History of prior head and neck radiation therapy.
- Subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding women are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation therapy, breastfeeding should be discontinued if the mother is treated with radiation therapy. These potential risks may also apply to other agents used in this study.
- The patient cannot have distant metastatic disease (or M1 disease by AJCC 8th edition).
Key Trial Info
Start Date :
December 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03768856
Start Date
December 7 2018
End Date
December 3 2019
Last Update
June 27 2022
Active Locations (1)
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1
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195